To make this happen, Parrish said, BioViva is applying to run human clinical trials outside of the United States, including in Africa and “a country in Europe.” It’s also partnering with other companies to open a gene therapy clinic somewhere in Central America where the regulatory regime allows patients to undergo consensual medical treatments that haven’t yet been fully tested.
Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics, said in an email to Seeker that there are reasons why there are so few FDA-approved gene therapies.
“Historically, they are very risky and have not shown efficacy,” wrote Kahn. “I don’t see how bypassing the oversight and approval process will do anything but expose more people to very significant risks without adequate protections or recourse.”
The death of Jesse Gelsinger from an experimental gene therapy in 1999 still casts a shadow over the field, likely fueling the FDA’s highly cautious position.
Parrish sees things very differently. The only way to truly know if these therapies work in human bodies — as opposed to mice or human cells in the lab — is to give patients the right to decide if the risk is worth it. And the more people who choose to undergo these therapies, the more data BioViva can collect and publish about their true risk and efficacy.
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BioViva’s initial focus will be on treating only the sickest and oldest patients who have exhausted other medical options, but Parrish says that eventually gene therapies will be administered “younger and younger” as a form of preventative medicine.
“We’re looking at a total paradigm shift,” said Parrish. “In 20 years, I believe that we’ll be giving a myriad of these gene therapies to people in their 30s. And that will provide the best defense against the complex diseases of aging. But right now we’ll use them in the sickest patients with the highest need.”
As part of this paradigm shift, Parrish explains, BioViva wants to commercialize its gene therapies more like a technology than a conventional drug. Today, when you get sick, you go to your doctor who gives you a prescription for an FDA-approved medication. Conversely, if you want some new app for your phone or upgraded hardware for your computer, you just go online and buy it. BioViva’s clinics will provide the same kind of on-demand upgrades, but this time to your DNA.
“It will all be done in a safe clinic with medical doctors and emergency staff, of course,” said Parrish, “But it’s literally just going and buying technology as you would buy technology for anything else in your life.”
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